Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00204347
• Collaborator: Janssen Pharmaceutica (Industry)
• Enrollment: 20
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. The secondary objective of this study (Study B)is to validate a self-report measure of clinical symptoms specific to the treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder	Drug: risperidone	Phase 4

Detailed Description

Study A: An open-label, prospective trial of the efficacy and safety of risperidone in the treatment of BPD.The study is 8 weeks in duration, with a screening visit and follow-up visits at the end of Weeks 1,2,3,4,6, and 8. 20 female patients, 19 years or older will be recruited. A full medical and psychiatric history will be taken and a physical exam will be performed by a sstudy physician. A psychosocial assessment will be conducted during the screen.

Study B: The ofjective is to validate the UAB BRS by administering the BRS and other neuropsychological instruments as repeated measures over a 6 week period to 40 patients with BPD.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder: The UAB Borderline Rating Scale (BRS)
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

1. Clinical Global Impression []

2. Brief Symptom Inventory []

Secondary Outcome Measures

1. Beck Depression Inventory []

2. Quality of Life Enjoyment and Satisfaction Questionnaire []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Diagnosis of BPD

Exclusion Criteria:

• Any other Axis I diagnosis except dysthymia, PTSD, or generalized anxiety disorder;substance abuse within a month; unstable medical illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35205

Sponsors and Collaborators

• University of Alabama at Birmingham
• Janssen Pharmaceutica

Investigators

• Principal Investigator: Celia T. Huston, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roberta May, Associate Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00204347
• Other Study ID Numbers: RIS-DED-WTJ
• First Posted: Sep 20, 2005
• Last Update Posted: Jun 10, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Roberta May, Associate Professor, University of Alabama at Birmingham: risperidone
• Additional relevant MeSH terms: Personality Disorders; Borderline Personality Disorder; Risperidone

Study Results

No Results Posted as of Jun 10, 2021